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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-04529 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| FIT DOM | Other Identifier | Mayo Clinic Women's Health |
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This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial/ethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.
PRIMARY OBJECTIVES:
I. To evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program for this community in Phoenix.
OUTLINE:
Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.
After completion of screening, participants with a positive FIT test are followed up at 2 and 4 weeks after initial outreach to assure participants have received adequate follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (FIT, education, questionnaire, patient navigation) | Experimental | Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Undergo education for colorectal cancer screening |
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| Measure | Description | Time Frame |
|---|---|---|
| Colorectal cancer disparities seen in people of color and minority populations | Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program. | Up to study completion, up to 30 days |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahaira J. Parker | Contact | 480-574-3171 | Parker.Yahaira@mayo.edu | |
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juliana M. Kling, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Fecal Immunochemical Test | Other | Undergo FIT testing |
|
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| Patient Navigation | Behavioral | Undergo patient navigation for positive FIT results |
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| Questionnaire Administration | Other | Complete questionnaire about colorectal cancer screening and healthcare |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |